1. Field of the Invention
The present invention relates to the field of medical safety devices, and more particularly, to a safety vise for the collection and disposal of used hypodermic needles from a reclaimable sleeve or syringe body, the safety vise having an associated disinfecting apparatus which is operably coupled to a viseing mechanism to prevent its subsequent use unless a disinfecting operation using the disinfecting apparatus has been performed, whereby disinfection of the reclaimable sleeve is encouraged. The safety vise is primarily intended for reclaiming the sleeve of a pistonless blood collection system, like VACUTAINER.RTM. assemblies, which are assembled from three independent sections: a sleeve, a specimen tube, and a double-ended needle. The design of the pistonless blood collection device requires that the safety vise have additional precautionary measures during the viseing procedure for removal of a double-ended needle.
2. Description of the Related Art
A major concern to those in the healthcare industry has been needle safety, primarily because the body of any container used in conjunction with blood handling is a potential carrier of disease and contamination. Used hypodermic syringe needles in particular are often infected with viral and bacterial pathogens which can lead to life-threatening diseases. Even as unused items, they portend a simple work-place hazard because they are extremely sharp and a skin puncture with a sterilized needle can provide an entry point for disease, especially at a medical facility.
Moreover, the problems associated with disease transmission by syringe use and disposal have imposed legal liabilities on professionals who must use them in practicing their art. Hypodermic syringe needles are prescribed medical items and desirable in drug trafficking. Therefore, to enforce regular prevention programs encouraging health and safety, medical facilities must execute prophylactic protocols or incur liabilities as dictated by law and regulation. One adopted protocol entails removing hypodermic syringe needles by a one handed technique to prevent inadvertent needle sticks.
However, used blood collection assemblies of a particular type using double-ended needles pose unique problems which have heretofore gone largely unaddressed. Referred to herein generally as a "pistonless blood collection system" and exemplified by the VACUTAINER.RTM. syringe and similar assemblies, these systems are well known and commonly used throughout the medical industry. To appreciate the problems such a system poses, an understanding of its components and its use is necessary.
A pistonless blood collection system is characterized generally as a pistonless, evacuated syringe for the collection of blood samples. The system consists of three separable components: 1) a blood specimen tube which is evacuated to a pressure below atmospheric and sealed with a rubber stopper; 2) a sleeve comprising a short transparent plastic cylinder accommodating both the rubber stopper and the specimen tube in a sliding fit within the chamber of the cylinder; and 3) a double-ended hypodermic needle, having an upper needle end designed to axially penetrate the rubber stopper, a lower needle end for insertion into a patient, and a threaded hub disposed around the needle intermediate the upper end and the lower end. The sleeve has an open end, into which the tube is inserted, and a closed end. The open end of the sleeve has flanges for grasping the cylinder between the index finger and middle finger. The closed end possesses a female threaded nozzle providing a passage into the chamber of the cylinder and shaped to accept the threaded hub of the double-ended hypodermic needle. The hub of the double-ended needle is matingly adapted to screw into the nozzle of the sleeve whereby the upper end of the needle resides wholly within the chamber. Details of such an assembly, may be viewed in FIG. 11 herein and are discussed further in the detailed description below.
In using the pistonless blood collection system, the double-ended needle is snugly screwed into the nozzle of the sleeve, forming an unitary syringe body. Thereupon, the specimen tube container is slipped, stoppered-end first, into the open end of the sleeve, being sure to avoid penetration of the rubber stopper by the upper needle end. The assembly is now ready for use. The operator grasps the cylinder of the sleeve in one hand (selectively between either, the index finger and thumb and the middle finger, or, the index finger and the thumb) below the flanges and penetrates the skin of the patient with the lower needle end. Having found the vein, the operator uses his thumb to press the specimen tube so that it slides forward within the chamber so that the upper needle end penetrates the center of the rubber stopper. A flow of blood results because of the differential pressure through the needle from the chosen vein of the patient into the specimen tube. After an adequate blood sample is obtained, the assembled syringe system is withdrawn from the patient.
The pistonless blood collection system is then disassembled. The filled specimen tube is stored for routing to the laboratory. The double-ended needle must be disposed as required. However, the plastic sleeve is salvaged for reuse by disinfecting it. Occasionally, in removing the specimen tube from the sleeve, blood residing in the upper needle is ejected into the plastic sleeve, resulting in contamination. Moreover, in removing the needle for disposal, even if the lower end is removed without incident by conventional means, the upper needle remains an exposed threat.
Thus, the use of a pistonless blood collection system poses two disease-transmission concerns. First, a concern exists over the potential for cross-contamination arising from the reuse of the sleeve. Specifically, a potential exists for spreading diseases by drawing infected blood from patients and passing it through the sleeve to subsequent patients requiring a blood draw. The second concern is the obvious threat posed by an exposed, potentially contaminated, double-ended needles.
No other invention is known to encourage the cleaning of the inside of the sleeve of a pistonless blood collection system before reuse. At best, the syringe bodies are currently soaked in a disinfectant or bleach on a random and unsystematic basis. Moreover, no other inventions mechanically couple a viseing mechanism with a disinfecting means.
The following U.S. patents are only generally relevant to the invention in so far as various means to accommodate removal and disposal of needles by a one-handed technique is described. Most notably, U.S. Pat. No. 4,989,307 to Sharpe et al. describes a phlebotomy syringe needle hub rotating mechanism which removes the double-ended needle for storage in a disposable needle enclosure. Although the use of only one hand is necessary to insert the syringe, the apparatus fails to provide means for adequate protection against an upper needle stick by the double-ended needle. Nor is the apparatus mechanically coupled with a disinfecting unit.
U.S. Pat. No. 4,380,292 to Cramer describes a parenteral needle receptacle, namely a foam block and case, which allows health care providers to temporarily dispose of a needle quickly and safely while only using one hand by inserting the needle into the foam block. U.S. Pat. No. 5,368,576 to Brown et al. describes a housing using a curable epoxy to permanently bind a needle penetrated into the housing. In U.S. Pat. No. 4,938,514 to D'Addezio, a needle cap holder, similar in appearance to a clothespin, is used to extend a needle cap away from the grasping hand to prevent needle sticks. U.S. Pat. No. 5,383,862 to Berndt et al. describes a device for enveloping and disinfecting sharp instruments comprising a folded pad-like sheet material to which an outer protective layer is attached and having microcapusules containing a disinfectant. Another device to laterally receive needles is a disposable, frictional gripper shown in U.S. Pat. No. 5,472,433 to Suzuki.
Other disinfecting devices are also relevant to the general concept of preventing the spread of disease by contact with blood. U.S. Pat. No. 5,427,234 to Upchurch describes a method and device for disposing syringes wherein a disposable container of a height less than that of a syringe needle contains an anti-microbic fluid into which the syringe needle is inserted. The fluid is repeatedly drawn into the syringe to ensure disinfection of the syringe and needle before the entire assembly is disposed. U.S. Pat. No. 5,168,612 to Schultz et al. describes a complex shearing machine for destroying and disinfecting hypodermic needles and syringes. U.S. Pat. No. 5,212,362 to Burden et al. describes an electrical apparatus using an electrode to create an electrical arc which volatilizes a sharp instrument.
For sake of full disclosure, the following patents are noted. WIPO Pat. Application 89/03987 dated May 5, 1989 describes an apparatus for quality control for manufacture of hypodermic needles. German Offenlegunsschrift 3 842 107 dated Jun. 21, 1990 describes a guard sheath first slipped over a syringe barrel and then unidirectionally and telescopically slid over the needle from the barrel.
None of the above inventions and patents, taken either singularly or in combination, describe the instant invention as claimed. Thus, the present invention is described which permits removal of a used needle from a pistonless blood collection syringe body or other syringe, and encourages disinfection of a syringe body to eradicate potential contamination on a salvaged syringe component. The present invention provides a solution to the aforementioned problems associated with the potential transmission of disease by improper handling of needles and syringe bodies.